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About the Australian therapeutic goods legislation

Therapeutic Goods Act 1989

The Act sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.

It details the requirements for listing, registering or including medicines, medical devices and biological products on the Australian Register of Therapeutic Goods (ARTG), as well as many other aspects of the law including advertising, labelling, and product appearance.

The Act is supported by the Regulations, and various Orders and Determinations which provide further details of matters covered in the Act. The Act is a Commonwealth Act that provides a substantially uniform national system of controls over therapeutic goods, facilitating trade between the states and territories and benefiting both consumers and industry.

Updates to the Therapeutic Goods Act 1989, Regulations, and various Orders and Determinations

The Act, Regulations, Orders and Determinations are amended from time to time. It is important to know the current regulatory requirements.

Changes are announced on the TGA website and in the TGA Update email sent out to subscribers.

Copies of the legislation can be obtained from the Attorney General's Department.

Other legislation

Other Commonwealth, state, and territory legislation may apply to certain medicines. The scheduling of substances in the Poisons Standard and the safe storage of therapeutic goods (e.g. by wholesalers) are also covered by state or territory legislation.

For further details on relevant state or territory legislation contact the health department in your state or territory.